Community Inclusion in PrEP Demonstration Projects: Lessons for Scaling Up

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Abstract

Pre-exposure prophylaxis (PrEP) has emerged as a new HIV prevention strategy. A series of demonstration projects were conducted to explore the use of PrEP outside of clinical trial settings. Learning from the failures in community consultation and involvement in early oral tenofovir trials, these PrEP projects worked to better engage communities and create spaces for community involvement in the planning and roll out of these projects. We describe the community engagement strategies employed by seven Bill & Melinda Gates Foundation-funded PrEP demonstration projects. Community engagement has emerged as a critical factor for education, demand generation, dispelling rumors, and supporting adherence and follow up in the PrEP demonstration project case studies. The increasing global interest in PrEP necessitates understanding how to conduct community engagement for PrEP implementation in different settings as part of combination HIV prevention.

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Most cited references 34

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Preexposure Chemoprophylaxis for HIV Prevention in Men Who Have Sex with Men

Robert M Grant, Javier R Lama, Peter L Anderson … (2010)

Antiretroviral chemoprophylaxis before exposure is a promising approach for the prevention of human immunodeficiency virus (HIV) acquisition. We randomly assigned 2499 HIV-seronegative men or transgender women who have sex with men to receive a combination of two oral antiretroviral drugs, emtricitabine and tenofovir disoproxil fumarate (FTC-TDF), or placebo once daily. All subjects received HIV testing, risk-reduction counseling, condoms, and management of sexually transmitted infections. The study subjects were followed for 3324 person-years (median, 1.2 years; maximum, 2.8 years). Of these subjects, 10 were found to have been infected with HIV at enrollment, and 100 became infected during follow-up (36 in the FTC-TDF group and 64 in the placebo group), indicating a 44% reduction in the incidence of HIV (95% confidence interval, 15 to 63; P=0.005). In the FTC-TDF group, the study drug was detected in 22 of 43 of seronegative subjects (51%) and in 3 of 34 HIV-infected subjects (9%) (P<0.001). Nausea was reported more frequently during the first 4 weeks in the FTC-TDF group than in the placebo group (P<0.001). The two groups had similar rates of serious adverse events (P=0.57). Oral FTC-TDF provided protection against the acquisition of HIV infection among the subjects. Detectable blood levels strongly correlated with the prophylactic effect. (Funded by the National Institutes of Health and the Bill and Melinda Gates Foundation; ClinicalTrials.gov number, NCT00458393.).

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Antiretroviral Prophylaxis for HIV Prevention in Heterosexual Men and Women

Jared Baeten, Deborah Donnell, Patrick Ndase … (2012)

New England Journal of Medicine, 367(5), 399-410

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Pre-exposure prophylaxis to prevent the acquisition of HIV-1 infection (PROUD): effectiveness results from the pilot phase of a pragmatic open-label randomised trial

Sheena McCormack, David T. Dunn, Monica Desai … (2016)

Summary Background Randomised placebo-controlled trials have shown that daily oral pre-exposure prophylaxis (PrEP) with tenofovir–emtricitabine reduces the risk of HIV infection. However, this benefit could be counteracted by risk compensation in users of PrEP. We did the PROUD study to assess this effect. Methods PROUD is an open-label randomised trial done at 13 sexual health clinics in England. We enrolled HIV-negative gay and other men who have sex with men who had had anal intercourse without a condom in the previous 90 days. Participants were randomly assigned (1:1) to receive daily combined tenofovir disoproxil fumarate (245 mg) and emtricitabine (200 mg) either immediately or after a deferral period of 1 year. Randomisation was done via web-based access to a central computer-generated list with variable block sizes (stratified by clinical site). Follow-up was quarterly. The primary outcomes for the pilot phase were time to accrue 500 participants and retention; secondary outcomes included incident HIV infection during the deferral period, safety, adherence, and risk compensation. The trial is registered with ISRCTN (number ISRCTN94465371) and ClinicalTrials.gov (NCT02065986). Findings We enrolled 544 participants (275 in the immediate group, 269 in the deferred group) between Nov 29, 2012, and April 30, 2014. Based on early evidence of effectiveness, the trial steering committee recommended on Oct 13, 2014, that all deferred participants be offered PrEP. Follow-up for HIV incidence was complete for 243 (94%) of 259 patient-years in the immediate group versus 222 (90%) of 245 patient-years in the deferred group. Three HIV infections occurred in the immediate group (1·2/100 person-years) versus 20 in the deferred group (9·0/100 person-years) despite 174 prescriptions of post-exposure prophylaxis in the deferred group (relative reduction 86%, 90% CI 64–96, p=0·0001; absolute difference 7·8/100 person-years, 90% CI 4·3–11·3). 13 men (90% CI 9–23) in a similar population would need access to 1 year of PrEP to avert one HIV infection. We recorded no serious adverse drug reactions; 28 adverse events, most commonly nausea, headache, and arthralgia, resulted in interruption of PrEp. We detected no difference in the occurrence of sexually transmitted infections, including rectal gonorrhoea and chlamydia, between groups, despite a suggestion of risk compensation among some PrEP recipients. Interpretation In this high incidence population, daily tenofovir–emtricitabine conferred even higher protection against HIV than in placebo-controlled trials, refuting concerns that effectiveness would be less in a real-world setting. There was no evidence of an increase in other sexually transmitted infections. Our findings strongly support the addition of PrEP to the standard of prevention for men who have sex with men at risk of HIV infection. Funding MRC Clinical Trials Unit at UCL, Public Health England, and Gilead Sciences.

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Author and article information

Contributors

Sushena Reza-Paul: Role: ConceptualizationRole: Writing – Original Draft PreparationRole: Writing – Review & Editing

ORCID: https://orcid.org/0000-0003-2716-1691

Lisa Lazarus: Role: Writing – Original Draft PreparationRole: Writing – Review & Editing

ORCID: https://orcid.org/0000-0002-7673-4671

Smarajit Jana: Role: Writing – Review & Editing

Protim Ray: Role: Writing – Review & Editing

Nelly Mugo: Role: Writing – Review & Editing

Kenneth Ngure: Role: Writing – Review & Editing

Morenike Oluwatoyin Folayan: Role: Writing – Review & Editing

ORCID: https://orcid.org/0000-0002-9008-7730

Florita Durueke: Role: Writing – Review & Editing

John Idoko: Role: Writing – Review & Editing

Luc Béhanzin: Role: Writing – Review & Editing

Michel Alary: Role: Writing – Review & Editing

ORCID: https://orcid.org/0000-0002-0246-4429

Daouda Gueye: Role: Writing – Review & Editing

Moussa Sarr: Role: Writing – Review & Editing

Wanjiru Mukoma: Role: Writing – Review & Editing

Jordan K. Kyongo: Role: Writing – Review & Editing

Rutendo Bothma: Role: Writing – Review & Editing

Robyn Eakle: Role: Writing – Review & Editing

Gina Dallabetta: Role: Writing – Review & Editing

Josie Presley: Role: Writing – Review & Editing

Robert Lorway: Role: Writing – Original Draft PreparationRole: Writing – Review & Editing

Journal

Journal ID (nlm-ta): Gates Open Res

Journal ID (iso-abbrev): Gates Open Res

Journal ID (pmc): Gates Open Res

Title: Gates Open Research

Publisher: F1000 Research Limited (London, UK )

ISSN (Electronic): 2572-4754

Publication date (Electronic): 17 December 2019

Publication date Collection: 2019

Volume: 3

Electronic Location Identifier: 1504

Affiliations

[1 ]Centre for Global Public Health, Rady Faculty of Health Sciences, Community Health Sciences, University of Manitoba, Winnipeg, Canada

[2 ]Ashodaya Samithi, Mysore, India

[3 ]Durbar Mahila Samanawaya Committee, Kolkata, India

[4 ]Center for Clinical Research, Kenya Medical Research Institute, Nairobi, Kenya

[5 ]Department of Global Health, University of Washington, Seattle, USA

[6 ]Department of Community Health, Jomo Kenyatta University of Agriculture and Technology, Nairobi, Kenya

[7 ]Department of Child Dental Health, Obafemi Awolowo University, Ile-Ife, Nigeria

[8 ]New HIV Vaccine and Microbicide Advocacy Society, Lagos, Nigeria

[9 ]Department of Medicine, University of Jos, Jos, Nigeria

[10 ]Centre de recherche du CHU de Québec, Université Laval, Quebec, Canada

[11 ]Dispensaire IST, Centre de santé communal de Cotonou 1, Cotonou, Benin

[12 ]École Nationale de Formation des Techniciens Supérieurs en Santé Publique et en Surveillance Épidémiologique, Université de Parakou, Parakou, Benin

[13 ]Département de médecine sociale et préventive, Université Laval, Quebec, Canada

[14 ]Institut national de santé publique du Québec, Quebec, Canada

[15 ]Institut de Recherche en Santé, de Surveillance Epidémiologique et de Formation (IRESSEF), Dakar, Senegal

[16 ]Westat, Inc, Rockville, USA

[17 ]LVCT Health, Nairobi, Kenya

[18 ]Wits Reproductive Health and HIV Institute (WRHI), Johannesburg, South Africa

[19 ]Faculty of Public Health and Policy, London School of Hygiene and Tropical Medicine, London, UK

[20 ]Bill & Melinda Gates Foundation, Washington, USA

[21 ]Bill & Melinda Gates Foundation, Seattle, USA

[1 ]Medical Research Council of Zimbabwe, Harare, Zimbabwe

[2 ]The George Washington University, Washington, DC, USA

[1 ]Global Health Research, FHI 360, Durham, NC, USA

[2 ]University of North Carolina Center for AIDS Research, Chapel Hill, NC, USA

[3 ]Social Medicine Department, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA

[1 ]Division of Infectious Diseases, St. Michael's Hospital, Toronto, ON, Canada

[2 ]St. Michael's Hospital, Toronto, Ontario, Canada

[1 ]Medical Research Council of Zimbabwe, Harare, Zimbabwe

[2 ]The George Washington University, Washington, DC, USA

Author notes

[a ] sushenar@ 123456gmail.com

No competing interests were disclosed.

Competing interests: No competing interests were disclosed.

Author information

Sushena Reza-Paul https://orcid.org/0000-0003-2716-1691

Lisa Lazarus https://orcid.org/0000-0002-7673-4671

Morenike Oluwatoyin Folayan https://orcid.org/0000-0002-9008-7730

Michel Alary https://orcid.org/0000-0002-0246-4429

Article

DOI: 10.12688/gatesopenres.13042.2

PMC ID: 6943951

PubMed ID: 31942537

SO-VID: de1b173a-a5d1-4e70-85d4-11533bd36eb3

License:

This is an open access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

History

Date accepted : 5 December 2019

Funding

Funded by: Bill and Melinda Gates Foundation

Award ID: OPP1084414

Award ID: OPP1104917

Award ID: OPP1056051

Award ID: OPP1104919

Award ID: OPP1098973

Award ID: OPP1084416

Funded by: Bill and Melinda Gates Foundation

Award ID: OPP1108606

This work was supported by the Bill & Melinda Gates Foundation (University of Manitoba: OPP1108606; University of Washington Foundation: OPP1056051, National Agency for the Control of HIV and AIDS: OPP1104917, Wits Health Consortium: OPP1084416, CHU de Quebec: OPP1098973, Reseau Africain de Recherche sur le SIDA: OPP1084414, LVCT Health: OPP1104919).

Community Inclusion in PrEP Demonstration Projects: Lessons for Scaling Up

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Most cited references 34

Preexposure Chemoprophylaxis for HIV Prevention in Men Who Have Sex with Men

Antiretroviral Prophylaxis for HIV Prevention in Heterosexual Men and Women

Pre-exposure prophylaxis to prevent the acquisition of HIV-1 infection (PROUD): effectiveness results from the pilot phase of a pragmatic open-label randomised trial

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